The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-341-2013·Announced 2013-05-22

Green Valley Drugs Recalls Amikacin Injection Due to Sterility Concerns

Green Valley Drugs is recalling Amikacin Injection because the pharmacy could not ensure the sterility of the compounded products. The recall covers all strengths and presentations of the drug.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a drug with sterility assurance failures (a significant safety risk) corresponds to a severity score of 4 (Severe), as it implies a reasonable probability of temporary or medically reversible health consequences.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling Amikacin Injection, all strengths and all presentations, including 50 mL and 30 mL vials. The product is prescription-only and was distributed nationwide. The specific lot number identified in the recall is 20130116-A, with an expiration date of 04/16/13.

The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes at the facility as the reason for the action.

Consumers and healthcare providers should stop using the recalled Amikacin Injection and contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Antibiotic Injection
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 20130116-A
  • Exp 04/16/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 78 products in this recall →

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